Integrated endoscope and accessory treatment device

ABSTRACT

An integrated endoscope and accessory treatment device is provided. The device employs a medical treatment device at its distal end that is combined with the endoscope as a complete system. The treatment device is controlled by integrated elements at the proximal end of the endoscope. The treatment devices may include tissue apposition devices, tissue cutting devices, forceps and others.

RELATED DISCLOSURE INFORMATION

[0001] The subject matter of the present application is related to thedisclosure document filed at the U.S. Patent and Trademark Office onSep. 7, 2000, and assigned Disclosure Document No. 479631.

FIELD OF INVENTION

[0002] This invention relates to endoscopes and devices and methods forcarrying out medical treatments using an endoscope.

BACKGROUND OF THE INVENTION

[0003] Viewing endoscopes permit remote treatment of internal locationswithin a patient by accessing those locations through a natural bodylumen avoiding the need for surgery in some cases. The advantages ofusing an endoscope to treat internal maladies of the human body has leadto the development of various endoscopic accessory treatment devicesthat can be fastened to the distal end of the endoscope to carry outmechanical manipulation and treatment of internal tissue areas. Examplesof such endoscopic accessories include suturing devices, cuttinginstruments, band ligating devices and forceps, among others. Theaccessories are securable to various types of endoscopes specificallydesigned for specific areas of the body and include: laparoscopes,duodenoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, andurethroscopes, among others. In combination with remote viewingcapability, endoscopes are frequently configured to provide a workingchannel through which controls for the scope mounted accessory may beinserted for remote operation.

[0004] Although an endoscope carrying a treatment accessory providesremote treatment capability while permitting direct visualization of thetreatment site, several shortcomings may arise in the use of thecombination. First, the separate accessory may limit viewing capabilitythrough the distal end of the endoscope when it is attached so as toextend distally from the distal face of the endoscope. Second, there isalways a risk that the accessory will become detached from the endoscopewhile in the patient, compromising the procedure and presenting problemsfor safely removing the detached accessory from the patient. Third, withvarious manufacturers producing endoscopes and accessories of differingdiameters, mounting a particular accessory to an endoscope can beproblematic if their diameters are not compatible. Fourth, the controlmechanisms for operating the accessory must extend through existingworking channels in the endoscope interfering with or prohibitingintroduction of additional accessories or instruments through theendoscope during the procedure. Also, the accessory controls may beawkward to mount and operate in conjunction with the endoscope as theendoscope was not originally designed to accommodate such additionalcontrols.

[0005] It would be advantageous to provide an endoscope and operativetreatment accessory that are designed to operate together to avoid theproblems mentioned above encountered with separate devices. It is anobject of the present invention to provide an integrated endoscope andtreatment accessory in a single structure that overcomes theshortcomings of the prior art devices mentioned above.

SUMMARY OF THE INVENTION

[0006] The present invention provides an integrated endoscope andtreatment accessory that is secure, reliable and easy to operateaccurately. The device comprises an endoscope shaft configured similarlyto conventional endoscope shafts and may be provided with a workingchannel, a channel for optical fibers for viewing capability and lighttransmission as well as auxiliary channels to provide viewing lenscleaning or additional working channel capability. The endoscope shaftfurther provides along its length space for the operative controlelements of the integrated treatment device placed at the distal end ofthe endoscope. The treatment device may consist of a housing in whichseparate, movable components are arranged to carry out the specifiedmedical treatment or procedure. Elements extending through the shaft ofthe endoscope such as cables, wires, or fluid pressure serve to operatethe components of the accessory. Because the accessory is integratedinto the endoscope, the viewing elements can be specifically arranged toprovide viewing capability of the location of the accessory wheretreatment will be carried out on tissue. Additionally, with controlelements for the accessory being integrated into the endoscope shaft,separate open working channels can be left free to receive other devicesor instruments in the overall diameter of the endoscope shaft need notbe increased dramatically by an externally applied accessory controlsheath or catheter.

[0007] The integrated endoscope and accessory may employ any type oftreatment device presently known to be applicable to an endoscope as aseparately attached accessory. Specifically, the integrated accessorymay comprise forceps, a mechanical or electrical cutting element,suturing device, band ligating device or other tissue manipulatingmechanism. The housing for the accessory is integrated into the shaft ofthe endoscope near its distal end appropriately positioned along theshaft for the treatment that will be carried out. The control mechanismsfor operating the accessory may be similar to conventional specificaccessories but will extend through spaces that are specifically formedthrough the endoscope to accommodate them. At the proximal end of theendoscope, an integrated control mechanism can be employed adjacent theendoscope distal end control mechanisms so that a user can operate bothsets of controls easily. Alternatively, the accessory controls can beintegrated with the endoscope controls for ease of use. Further theaccessory controls can be positioned at any convenient location alongthe length of the endoscope where the physician would ordinarily graspthe endoscope shaft to control its movement in the patient.

[0008] Although the integrated accessory may comprise any type oftreatment device known to be usable with endoscopes, the followingdetailed description illustrates the example of an integrated endoscopeand accessory device through the example of a tissue suturing deviceintegrated into a gastroscope. It will be understood that those skilledin the art that the examples provided herein can be easily modified toaccommodate other types of accessories for practicing other types oftreatments.

[0009] It is an object of the invention to provide an integratedendoscope and medical treatment device accessory.

[0010] It is another object of the invention to provide a method forusing an integrated endoscope and medical treatment device accessorythat reduces the number of steps and instruments required to complete anendoscopic procedure

BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The foregoing and other objects and advantages of the inventionwill be appreciated more fully from the following further descriptionthereof, with reference to the accompanying diagrammatic drawingswherein:

[0012] FIGS. 1-3 show successive steps in the operation of a prior artsingle stitch sewing device;

[0013] FIGS. 4A-4D are views of multiple suction port apposition devicesin various stages of operation;

[0014]FIG. 5A is a partial sectional side view of an integratedendoscope and treatment device accessory;

[0015]FIG. 5B is a sectional view of the integrated endoscope of FIG. 5Ataken along the line 5B-5B;

[0016]FIG. 6 is an isometric view of an embodiment of the integratedendoscope and medical device treatment accessory comprising acylindrical cartridge assembled over the distal end of the endoscope;

[0017]FIG. 7 is an isometric view of an embodiment of the integratedendoscope and medical device treatment accessory wherein the cylindricalcartridge has been removed from the distal end of the endoscope;

[0018]FIG. 8 is a sectional view of the integrated endoscope shown inFIG. 6 taken along the line 8-8;

[0019]FIG. 9 is a side view of the plug portion of a tissue appositionmeans device;

[0020]FIGS. 10A and 10B are views of the ring portion of a tissueapposition means;

[0021]FIG. 11 is a sectional view of an alternate embodiment of thecylindrical cartridge shown in FIG. 6, taken along the line 8-8;

[0022]FIG. 12 is a top view of the suction port of the cylindricalcartridge shown in FIG. 11;

[0023]FIG. 13 is a diagrammatic illustration of two tissue portionsafter being aspirated into the suction port shown in FIG. 12;

[0024]FIG. 14 is an illustration of tissue portions secured together bythe apposition device shown in FIGS. 9-10B;

[0025]FIG. 15 is a side sectional view of tissue portions capturedtogether by the tissue apposition device of FIGS. 9-10B;

[0026]FIG. 16 is a side sectional view of tissue portions capturedtogether by a modified version of the tissue apposition device shown inFIGS. 9-10B;

[0027]FIG. 17 is a detailed view of the trigger mechanism of thecylindrical cartridge shown in FIG. 6;

[0028]FIG. 17A is a top view of a portion of the reduced diameterportion of the integrated endoscope shown in FIG. 7;

[0029]FIG. 18 is a top view of an endoscope control handle employing atrigger lever;

[0030]FIG. 19 is a variation of the cylindrical cartridge integratedendoscope embodiment employing a modified reduced diameter portion;

[0031]FIG. 20 is a sectional side view of an integrated endoscope andaccessory applying a semicircular needle for placing sutures throughcaptured tissue portions;

[0032]FIG. 21 is a side view of an integrated endoscope employingadditional optics and optic cleaning ports;

[0033]FIG. 22 is a side partial sectional view of an integratedendoscope employing an angulated distal face;

[0034]FIG. 23 is a partial sectional side view of an integratedendoscope employing a tissue apposition accessory that deploys staples;

[0035]FIG. 24 is a top view of an integrated endoscope employing atissue apposition device that deploys staples;

[0036]FIG. 25 is an isometric partial sectional view of an integratedendoscope and accessory employing multiple access ports;

[0037]FIG. 26 is a series of three views of an integrated endoscope witha single access port and grasping device in various stages of operation.

DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

[0038] The present invention provides an endoscope with an integratedmedical device treatment accessory at its distal end. The devicescontemplated for integration with the endoscope include tissueapposition devices, forceps or tissue cutting instruments. Severalembodiments of the integrated endoscope employing tissue appositiondevices are presented below.

[0039] In one embodiment of the integrated endoscope, the tissueapposition device as disclosed in U.S. Pat. No. 5,792,153 may beemployed. The '153 patent is incorporated by reference herein in itsentirety. A brief explanation of the configuration and operation of theprior art tissue apposition device is presented with reference to theprior art FIGS. 1-3.

[0040] FIGS. 1-3 depict a prior art endoscopic suturing device disclosedin U.S. Pat. No. 5,792,153. FIG. 1 shows the distal end of a flexibleendoscope 1, on which a sewing device 2 is attached. The endoscope isprovided with a viewing channel, which is not shown, but whichterminates at a lens on the distal face of the endoscope. The endoscopeis further provided with a biopsy or working channel 3, and a suctionchannel 4 the proximal end of which is connected to a source of vacuum(not shown). The suction channel 4 may comprise a separate tube thatruns along the exterior of the endoscope, rather than an internal lumenas shown. The sewing device 2 has a tube 5, which communicates with thesuction pipe 4 and has a plurality of perforations 6 therein. Theseperforations communicate with an upwardly open vacuum chamber 7 formedin the sewing device.

[0041] A hollow needle 8 is mounted in the biopsy channel 3, with itsbeveled tip extending into the sewing device. The needle has a channel 9extending therethrough. A flexible, wire-wound cable 10 has its forwardend attached to the rear of the needle 8, and a center wire 11 runswithin the cable 10, along the entire length thereof, and islongitudinally movable with respect thereto. The diameter of the wire 11is such that it is longitudinally movable within the channel 9 and, inthe position shown in FIG. 1, the forward end portion of the wire 11extends into the rear end portion of the channel 9. A thread carrier inthe form of a tag 12 is slidably and releasably mounted in the channel9. The tag is shown in detail in FIG. 1A. The tag is hollow and has anaperture 13 extending through the sidewall thereof. As can also be seenin FIG. 1, one end of a thread 14 is secured to the tag by passing itthrough the aperture 13 and tying in the end of a knot 15 of sufficientsize to prevent the thread escaping from the tag. The tag may be madefrom a relatively rigid material such as stainless steel.

[0042] At the distal end of the sewing device is defined a hollow headportion 16 defining a chamber 20 therein. Between the chamber 20 and thecavity 7 is a wall 17, in which an aperture 18 is formed. The aperture18 has a diameter that is marginally greater than the external diameterof the needle 8, and is aligned therewith. The clearance between theneedle 8 and the aperture 18 must be sufficiently small to preventtissue being forced through the aperture and causing the needle to jam.Finally, FIG. 1 shows a portion of the patient's tissue 19, in which astitch is to be formed.

[0043] In operation, suction is applied to the suction pipe 4, andthence, via the perforations 6 in the tube 5 to the cavity 7. This sucksinto the cavity a U-shaped portion 19 a of the tissue 19, as shown inFIG. 2. The hollow needle 8 is pushed through the U-shaped tissueportion 19 a by extending distally the wire-wound cable 10 andassociated needle 8. After full advancement of the needle through bothfolds of the U-shaped tissue portion, the tip potion of the needle 8 isdistal to the wall 17 and within the chamber 20 in the hollow headportion 16. Distal movement of wire 11, slidably received within thewound cable 10, pushes the tag 12 out of the channel 9 and into thechamber 20 where it rotates out of alignment with aperture 18 to becomecaptured in the chamber.

[0044] The wire 11 is then withdrawn proximally, followed by proximalwithdrawal of the cable 10, to withdraw the needle 8 from the tissueportion 19 a. The suction is then discontinued allowing the U-shapedtissue portion 19 a to be released from the cavity 7. As shown in FIG.3, the released tissue is left with a suture thread 14 passing throughthe two layers of tissue that form the U-shaped fold 19 a. One end ofthe suture is joined to the tag 12 that remains captured in the chamber20 and the other end of the suture extends through the patient'sesophagus and out of the mouth. Finally, the endoscope and dewing deviceare withdrawn from the patient. In so doing, the thread 14 is pulledpartially through the tissue portion 19 a, as the captured tag 12 iswithdrawn proximally and brought outside the patient. With both ends ofthe thread 14 outside of the patient, the thread can be knotted and theknot endoscopically pushed down to the suture site and severed by anendoscopic knot pusher such as that disclosed in U.S. Pat. No. 6,010,515(Swain et al).

[0045] For certain treatments, capturing multiple tissue portions,gathering and holding them together may be desirable. FIGS. 4A-4Cillustrate the operation of a multiple suction port apposition device 50as disclosed in co-pending U.S. application Ser. No. 10/220,379. The'379 patent application is incorporated by reference herein in itsentirety. The device can capture multiple tissue portions 52simultaneously for application of a tissue securing device, such as asuture, tag or staple. The device may be modified to deliver the tissuesecuring devices of the present invention. Securing two tissue portions52 in the same number of steps that the prior art device requires tosecure a single tissue portion doubles efficiency, reducing the totalnumber of endoscopic intubations required to complete the procedure andreducing the time needed to complete the procedure. Though dual suctionport embodiments are discussed for illustration purposes, it should beunderstood that the multiple port device also could be configured tohave three or more suction ports.

[0046] The dual suction port tissue apposition device shown in FIG. 4Apasses through both tissue portions a suture 56 with a tag 58 capturablein the end cap 60 of the sewing capsule 62, in similar fashion to theprior art device discussed in connection with FIGS. 1-3 above. The dualsuction port tissue apposition device shown in FIG. 4B passes throughboth tissue portions a suture 64 having a permanent tag 66 at its end.In this embodiment, the permanent tag is not captured by the suturingdevice to later provide a lead for tying a surgical knot. Rather, thepermanent tag remains in the body, anchored on the through side 68 ofthe distal tissue portion. The tissue portions may then secured tightlytogether, not by a surgical knot, but by a frictionally engageable twopiece suture lock device 70 advanced along the single suture lead 64 toabut the proximal side 72 of the tissue portion.

[0047] In one embodiment of the multiple suction port device, themultiple suction ports are defined in line on the sewing device, along acommon longitudinal axis that is parallel to the longitudinal axis ofthe device. An isometric view of an in-line dual suction port endoscopictissue apposition device 50 is shown in FIGS. 4C. In FIG. 4C, a slottedand beveled hypodermic suturing needle 80 is in the fully retractedposition, with suture tag 68 not yet loaded, and the capsule ready toreceive tissue. The sewing device 50 is characterized by a tubular bodyor capsule 74 that is machined from metal or injection molded from arigid polymer material. The body may be formed with an atraumatic distaltip 76 to avoid injury to the walls of a body lumen through which thedevice is delivered.

[0048] A plurality of suction ports 86 are formed into the body alongits length. Suction ports 86 are large openings defined through thecapsule 74, and open to one or more vacuum chambers 82. The chambers aredefined in the capsule by surfaces forming sidewalls 84. Communicationof the suction ports with the vacuum chambers 82 permits vacuum to reachtissue that is adjacent to the ports to accomplish capture of tissueportions 52 into the chamber. Any number of suction ports can be formedon the capsule body. However, two suction port devices are shown here asillustrative examples because often in the treatment of GERD, a seriesof two tissue mounds joined together are formed along the stomach wall,below the Z-line. Though more ports and chambers can be formed on thebody, the extra body length they would require in the in-line embodimentcould potentially present difficulty during navigation of the rigid bodythrough the curves of a natural body lumen.

[0049] Tissue portions are drawn into the suction ports and into thevacuum chambers by suction introduced to the chambers through airpassages 88. The air passages are open to independent internal channelsin the body that are joined to vacuum lines 90. The vacuum lines extendfrom the proximal end of the capsule body, external to the endoscope, tothe proximal end of the scope. Outside the patient, the vacuum lines canbe joined to a portable or institutional vacuum source (not shown). Acontrol valve may be inserted in-line near the proximal end of the tubesfor selective control of the vacuum by the user. The air passages of allcambers may be joined and controlled by a single vacuum line.Alternatively, as shown in FIG. 4C, separate vacuum lines may be used tosupply suction to the air passages of different vacuum chambers. Use ofseparate vacuum lines permits independent control of suction provided tothe several chambers by the use of separate control valves for eachvacuum tube at their proximal ends.

[0050] Independent vacuum supply to the air passages of each chamber notonly helps to ensure adequate vacuum pressure to each chamber, but alsopermits sequential suctioning of tissue into the chambers. When tissueis collected into both chambers simultaneously, the distal chamber isblocked from the viewing lens 48 on the distal face 46 of the endoscope1, as shown in FIG. 4B. Therefore, the physician is unable to visuallydetermine whether tissue has been adequately collected into the vacuumchamber so that the needle 80 can be safely advanced through. Byapplying vacuum first to the distal chamber, tissue collection into thatchamber can be visually verified before the view is blocked by tissueentering the proximal chamber. Next, vacuum can be applied to theproximal chamber to capture tissue so that tissue is collected in bothchambers simultaneously and held in readiness for penetration by thesuture needle (or staple) through both tissue portions with one stroke.However, even with independent vacuum lines, it is possible, and may bedesirable to apply a vacuum to all chambers simultaneously.

[0051] The needle 80 is longitudinally slidable through the capsule body50, as in the prior art devices. In the in-line dual chamber embodimentshown in FIG. 4C, a tunnel-like needle track 92 extends longitudinallythrough solid portions in the upper half of the body, not otherwisedefined by the vacuum chambers. From the needle track, a thin suturechannel 94 extends upwardly through the top surface of the capsule bodyto provide a space through which the suture lead 64 may pass as thesuture tag 68 is advanced by the needle through the needle track 92. Thechannel 94 is only a sufficient width to permit the suture to pass butis too small to permit passage of the larger needle or suture tag 68.The small dimension of the channel helps maintain the needle and suturetag with in the needle track until they are extended distal to the mostdistal chamber. An enlarged exit channel 96 extends upwardly from theneedle track along the body a short distance distally from the distalchamber 82. The enlarged channel facilitates exit of the suture tag 68from the body, to follow the released tissue to which it has beenattached after being ejected from the extended needle 80 by pusher wire98. Additionally, a ramp 99 may be formed in the bottom surface of theneedle track along the length of the exit channel 96. Extending upwardlyas it extends distally, the ramp 99 helps guide an ejected tag up andout from the exit channel and away from the capsule body. A detailedisometric view of the dual suction chamber device of FIG. 4A in whichthe tag 58 is captured in the distal end 76 of the device is shown inFIG. 4D.

[0052] The prior art tissue apposition devices may be integrated withthe endoscope shaft as shown in FIG. 5A, which presents a sectional viewof the distal tip of the endoscope, through the working end of theapposition component. The integrated endoscope 51, shown in FIG. 5A,comprises an endoscope shaft 53 and handle 89 having controls 57 forarticulation of the endoscope distal tip 59. Also integrated into handle89 at the proximal end 55 of the endoscope shaft may be controls for theoperation of the accessory, including controls configured as shown inU.S. Pat. No. 5,910,105, incorporated by reference herein in itsentirety.

[0053] The tissue apposition device 61 located at the distal end 59 ofthe endoscope is configured similarly to the device discussed inconnection with FIGS. 103 above. The apposition portion 61 comprises avacuum chamber 63 into which aspirated tissue is collected in aplurality of suction ports 65 long the bottom of the vacuum chamber 63for introduction of vacuum to selectively capture tissue into thechamber. The vacuum chamber 63 may be formed from transparent polymermaterials to improve visibility of the tissue as captured into thechamber and illumination provided by several light ports integrated intothe endoscope. Shown in phantom in FIG. 5A is a needle pathway 67 alongwhich the needle may be moved longitudinally through a captured tissueportion. Beneath the chamber, the endoscope continues distally anterminates at distal face 91. At the distal tip of the appositionportion is provided a removable cap 69, which provides a chamber intowhich a suture carrying tag may be injected as discussed above in theoperation of the prior art device of FIGS. 1-3.

[0054]FIG. 5B is a sectional view of the integrated endoscope shaft 53taken along the line 5B-5B in FIG. 5A. In the sectional view, anexemplary arrangement of channels and endoscope components is shown. Itshould be understood that other arrangements of the channels andcomponents may be employed and such alternate arrangements should not beconsidered to depart from the spirit of the present invention. Theseveral channels and components shown in FIG. 5A each extend the fulllength of the endoscope shaft 53 from the proximal end 55 where they maybe accessed or controlled by the user, through to the distal end 59 ofthe shaft at the apposition portion 61.

[0055] A biopsy channel 71 is provided through which the needle endcontrol wire to move the needle 67 may be inserted. The biopsy channelmay measure a diameter of approximately 0.110 inches. Several lightchannels 75 are provided through which optical fibers pass to transmitlight from the proximal end 55 of the endoscope to the workingapposition portion of the endoscope. One fiber terminating at theproximal wall 73 of the vacuum chamber 63. Two other light channelsterminating at distal face 91. A main objective lens 77 for viewing isprovided and carries an optical fiber through the endoscope shaft to theproximal end 55 of the endoscope. Additionally, a side viewing objectivelens 79 may be provided, also carrying an optical fiber through theendoscope shaft 53 to the proximal end 55. An internal vacuum line 81provides vacuum at the distal end 59 of the endoscope shaft from avacuum connection at the proximal end 55. Additionally, air and waterports 83 and 85 may be provided through the shaft for providing cleaningmeans for the main viewing lens 77.

[0056] Several articulation wires 87 are also provided through theendoscope shaft 53 for the purpose of bending and curving the distalportion of the shaft as it is navigated to the treatment site. Thearticulation wires are anchored near the distal portion 59 of theendoscope shaft and extend proximally to the control knobs 57 on thehandle 89 of the endoscope. It is noted that though the endoscope shaft53 may be made flexible, the distal working portion 59 comprising theapposition device 61 will be rigid to ensure smooth movement of therigid needle 67 required for tissue penetration. Accordingly, thearticulation of the endoscope shaft will be just proximal to theapposition portion. With the exemplary lumens and components describedabove, it is expected that the endoscope shaft will have an outsidediameter on the order of 0.550 inches. Finally, it is noted that theabove-described embodiment can be carried out in an apposition portion61 having multiple vacuum chambers 63 as is shown in FIGS. 4A-D. Detailsof the operation and configuration of the multiple chamber appositiondevice may be found in U.S. patent application Ser. No. 10/220,379,incorporated by reference herein in its entirety.

[0057]FIG. 6 shows another embodiment of an integrated endoscope 100having a tissue apposition device 102 at its distal end 104. The tissueapposition portion 102 comprises a removable cylindrical cartridge 106that is received over a reduced diameter core section 108 of theendoscope, shown in FIG. 7. The cylindrical cartridge defines a suctionport 110 and vacuum chamber 112 into which a tissue portion may becollected under vacuum. The cartridge also holds tissue capturing meansthat are delivered into the tissue along a circumferential path relativeto the longitudinal axis of the endoscope. The cartridge may bepreloaded with the tissue capture means and may be made as a one-timeuse item that is disposable after use. The cartridge may be secured tothe endoscope by a screw 114 threaded into screw hole 116 on a distalface 118 of the endoscope prior to its reduction to the reduced diameterportion 108.

[0058] Through the reduced diameter core portion 108 extend passages forconventional endoscope elements. A combination suction lumen and workingchannel 120 is provided to carry elongate medical instruments. Atelescoping and rotational objective lens 122 is provided as well as afixed objective lens 124 for providing viewing capability to theproximal end of the endoscope. A light guide 126 may be provided at thecenter of the reduced diameter portion 108 to illuminate areas viewedthrough the objective lenses. An air and water port 128 may be providedas a cleaning means for the objective lenses. Also provided is a sidesuction port 130 on the side wall of the reduced diameter portion 108for communicating vacuum to the vacuum chamber 112 of the cylindricalcartridge. Also provided on the side wall 132 of the reduced diameterportion 108 are dual trigger mechanisms 134 (shown in phantom) thatslide longitudinally to operate the tissue capture means releasemechanism in the cylindrical cartridge.

[0059] The specific structure of the cylindrical cartridge 106 is shownin the sectional view presented in FIG. 8, taken along the line 8-8 ofFIG. 6. In FIG. 8, a tissue portion 138 is shown aspirated and collectedinto vacuum chamber 112 through suction port 110 of the cartridge. Asingle mound of tissue 138 may be collected or two separate moundscollected if a partition is placed midway along the length of thesuction port 110 to define two separate mounds of tissue. The cartridgecarries two sets of tissue apposition means comprising a plug 140insertable through the tissue and engaging with a fastening ring 142 onthe through side of the tissue. A detail of the plug is shown in FIG. 9.Details of the ring are shown in FIGS. 10A and 10B.

[0060] The plug is pre-loaded and retained in a circumferential firingchamber 144 defined in the annular cross section of the cylindricalcartridge 106. The plug is curved to follow the arc shape of the firingchamber 144. The plug has a sharp piercing end 148 to penetrate tissueand a flat enlarged diameter cap portion 150 that is engaged by a firingspring 151 to drive the plug circumferentially through the capturedtissue 138 and into the ring 142 frictionally held in a ring receptacle152 formed in the cartridge 106. Because the plug 140 travels along theoutside wall 156 of the firing chamber during its travel, the enlargedflat head 150 is offset from the center of the plug body to fullycapture the driving force of firing spring 151 and to keep the plug 140aligned within the firing chamber 144 as it is advanced.

[0061] The firing spring 151 is held in a compressed configuration bytrigger 156 until delivery of the plug through a captured tissue portionas desired. The trigger can be pulled out of the way from the spring bya remote connection to the proximal end of the endoscope as will beexplained below. When the spring is released, it expands along thecircumferential pathway and defined by the firing chamber 144 and pushesthe plug 140 through the tissue. As the plug is fired, the plug body 146becomes frictionally engaged in ring through hole 158. Shown best inFIGS. 10A and 10B, the ring through hole is not concentric with theoutside diameter of the ring, but is located at one side of the ring tomatch the alignment of the offset plug body 146 relative to the plughead 150. Additionally, the through hole 158 is configured to tapergradually in diameter to a ridge 160 of reduced diameter in its centerfor the purpose of enhancing frictional engagement with the plug body146.

[0062] The plug body 146 is made of a series of larger diameter ribs 162that further enhance frictional engagement with the ring as they meetpeaks of resistance as they align with the ridge 160 of the through hole158 in the ring. As mentioned above, the cartridge 106 may be configuredto hold two or more ring and plug assemblies spaced apart longitudinallyby approximately one centimeter so that the tissue portion is securedsimultaneously by two ring and plug assemblies. If a dividing wall isplaced in the suction port 110, dividing it in half longitudinally, thentwo separate tissue mounds are formed and captured separately by the tworing and plug assemblies.

[0063] In an alternate arrangement, the suction port 110 may be dividedby a partition wall extending longitudinally, as shown in FIGS. 11-14.As shown in FIGS. 11 and 12, the cylindrical cartridge 106 may beprovided with a suction port 110 having a partition wall 164 extendinglongitudinally along its length. When the tissue portion is aspiratedinto the vacuum chamber 112, it is partitioned around the wall 164 toform two distinct mounds 138 as shown in FIGS. 11 and 13.

[0064] As shown in FIG. 12, the partition wall 164 extends across thesuction port 110. The overhead view of the suction port 100 as shown inFIG. 12 demonstrates that vacuum is introduced into the vacuum chamberthrough suction holes 111 spaced throughout the vacuum chamber 112.Firing chambers 144 located at the bottom of the suction chamber, arearranged to aim the sharp piercing tip 148 of the pre-loaded plugsoutward into tissue along a circular path so that they curve aroundthrough the two mounds of tissue segregated by the partition wall 164and enter the rings 142 frictionally held in ring retainers 152positioned on the opposite side of the vacuum chamber 112.

[0065] After the plugs 140 have been driven through the tissue andengaged with the rings 142 on the opposite side of the vacuum chamber,aspiration is discontinued and the tissue mounds 138 captured by theplug and ring 140 and 142 appear as shown in FIGS. 14 and 15. The plug140 is inserted through both mounds of the partitioned tissue 138 andholds the tissue together in separate mounds with large cap 150 bearingon one side of the tissue and the ring 142 bearing on the other side ofthe tissue and locked onto the tip of the plug 140. In FIG. 16 is shownan alternate embodiment of a ring 162. The ring performs in the samemanner as ring 142 but includes an extended cylindrical portion 164 thatextends over the protruding sharp distal tip 148 of the plug so thatadjacent tissue areas are not injured by the piercing tip.

[0066]FIG. 17 shows a detailed drawing of the trigger 156 and triggermechanism 134 that selectively releases the firing spring 151 to deliverthe plug into the ring. The trigger 156 comprises a spring engagingportion 166 that is slidably engaged with the inner side wall 168 of thecartridge 106. The spring engaging portion is pinned to a curved portion170 of the trigger that extends through a trigger slot 172 and engagesthe trigger mechanism 134 that is slidably positioned on the exteriorsurface 132 of the reduced diameter portion 108 of the endoscope. Thetrigger mechanism 134 extends through a slot 174 formed through the wallof reduced diameter portion 108 and forms an eyelet portion 176 thatreceives a trigger cable 178 that extends through the length of theendoscope shaft 53 to the handle 89 where it is joined to the workingend of a trigger lever 180 that extends to the exterior of the handlefor activation by the user as shown in FIG. 18. When the lever isoperated as shown by arrow 182 in FIG. 18, the trigger cable 178 ispulled proximally, which serves to slide trigger mechanisms 134proximally as shown in the top view—FIG. 17A). Movement of the triggermechanism 134 proximally pulls the curved portion 170 and entire trigger156 proximally such that the spring engaging portion 166 is pulled clearof the firing spring 151, allowing it to release and fire the plug alongits circumferential path in the firing chamber 144.

[0067] In FIG. 19 is shown an alternate embodiment of the cylindricalcartridge apposition device. The modified endoscope 185 has a reduceddiameter portion 108 for receiving the cylindrical cartridge 106 as withthe previous embodiment discussed in connection with FIGS. 6 and 7;however, the endoscope further includes a viewing lens 124 and lightsource 184 on the large diameter end face 118 to provide additionalviewing capability. Specifically, the additional viewing lens and lightsource will permit the operator to directly view tissue being suctionedinto the vacuum chamber 112 of the cylindrical cartridge (not shown inFIG. 19). The vacuum chamber of the cylindrical cartridge may haveadditional cutouts to eliminate walls that would otherwise obstruct theviewing capability of the lens 124. Accordingly, sealing gaskets 186 areemployed around the areas that will be overlayed by the vacuum chamber112 when the cartridge is fitted over the reduced diameter portion 108of the endoscope. The gaskets will help to ensure a sufficient vacuum isgenerated in the vacuum chamber to aspirate tissue completely beforefiring of the plug and ring tissue apposition elements.

[0068] Additionally, sensors 188 may be placed adjacent to suction holes111 on the side wall surface 132 of the reduced diameter portion 108that signal when tissue has been fully aspirated into the vacuum chamberof the cartridge and send an electrical signal to the proximal end ofthe endoscope that can notify the user that sufficient aspiration hasbeen obtained and firing of the tissue capture means can be commenced.

[0069]FIG. 20 shows another embodiment of a tissue apposition devicethat may be embodied at the distal end of an integrated endoscope. Theapposition device 200 employs a semicircular needle 202 driven through acircular pathway 204 that is defined by two pairs of opposed pulleys 206and 208. The circular pathway 204 guides the needle through a vacuumchamber 210 which captures a tissue portion 138 by aspiration whenvacuum is introduced through vacuum holes 212 at the bottom of thesuction chamber.

[0070] As mentioned above, the needle 202 travels through a circularpathway 204 defined by two sets of pulleys 206 and 208 and a circularneedle track 214 that is formed at the distal end of the device 200 suchthat at least a portion of its arc travels through the vacuum chamber210 so that the needle will pass through the tissue. Needle track 214 isa circular passage of a diameter slightly greater than that of theneedle to guide the needle as it is driven by pulleys. The sets ofopposing pulleys each comprise a driver pulley 206 and an idler pulley208 that is opposed to the driver pulley. To drive the needle, thedriver pulleys are adjusted to move slightly into the needle track 214,closing the distance with the idler pulley so that the needle 202becomes trapped therebetween. When the driver pulleys 206 are rotated,their engagement with the needle will cause the needle to move throughthe needle track 214 to complete a circular cycle. The driver pulleysmay be moved into an out of engagement by mechanical linkage controlledat the proximal end of the endoscope (not shown).

[0071] The driver pulleys 206 are driven by a driver cable 216 threadedaround each pulley and around an idler pulley 208 and extendingproximally through the endoscope to be driven by an external source.When moved in the direction designated by arrows 218, the needle will bedriven in a penetrating direction to deliver attached suture thread 220through a tissue portion 138. After the needle has been passed throughthe tissue portion 138, vacuum may be discontinued to release the tissueportion and the distal tip of the endoscope moved to a new location,tissue aspirated and the needle again moved through its circular path todeliver the same suture lead. After placing sutures through the desirednumber of tissue locations, the device may be withdrawn carrying thethreaded suture 220 proximally outside of the patient where knots may beapplied or suture lock devices assembled onto the suture to secure itand complete the procedure.

[0072]FIG. 21 shows another embodiment of the multiple suction porttissue apposition device shown in FIGS. 4A-4D. In particular, FIG. 21shows an integrated endoscope 222 having multiple suction chambers 224into which tissue may be aspirated by introduction of vacuum throughvacuum holes 226. In addition to the working channel lumen 228 andvacuum lumen 230, the endoscope is configured with additional viewingports 232 and complementary adjacent cleaning ports 234. The viewingports 232 join to a lumen 236 containing an optical fiber extendingthrough to the proximal end of the endoscope and through which viewingcapability is obtained. The cleaning ports 234 open to a lumen extendingproximally to the proximal end of the endoscope that permit ejection offlushing liquid and air to clean the viewing port lens 232.

[0073] The viewing and cleaning ports of the distal tip 240 of thedevice aid in navigating the endoscope to the intended tissue locationby providing a viewing vantage point that is not obstructed by thestructure of the apposition device. The viewing and cleaning ports 232and 234 that terminate in the bottom of the vacuum chamber 242 areuseful in observing when the complete tissue mound has been aspiratedinto the chamber. When a tissue mound is fully collected, it contactsthe face of the viewing port 232 causing a “pink-out” condition thatverifies for the operator that a complete tissue portion has beenaspirated and it is safe to deliver the needle carrying a suture throughthe tissue mound.

[0074]FIG. 22 is a side partial sectional view of another embodiment ofthe integrated endoscope having a tissue apposition device 250integrated at its distal end 252. The device utilizes an angulated tippresenting a distal face 254 that is angled away from the longitudinalaxis of the endoscope by approximately 45°. A suction port 256 is formedon the distal face for receiving tissue aspirated into the vacuumchamber 258. Along the back wall 260 of the vacuum chamber are locatedseveral conventional accessory ports found on the endoscopes of otherembodiments described in the application.

[0075] Specifically, a vacuum port 262 is provided that may be joined totwo channels so that either vacuum or pressure for insuflation may beintroduced through the same port and into the vacuum chamber 258. Alsoon the back wall is a viewing lens 264 joined to an optical fiber and anair and water port 266 for cleaning the lens. A rigid needle 268 isdirected through a pathway that follows the longitudinal axis of theangulated distal face 54 in order to traverse the vacuum chamber 258squarely so that captured tissue is accurately penetrated. The needle268 is advanced by the longitudinal movement of a flexible pusher 270that is able to traverse the 45° angle corner 272 within anappropriately formed sliding lumen and has sufficient column strength todrive the needle through tissue. The needle may be hollow and deliver apermanent tag through its lumen to secure the tissue with suture asshown in the embodiment of FIGS. 4A and 4C of the prior art devices.

[0076]FIG. 23 shows another embodiment of the integrated endoscopecomprising an apposition device 280 that drives a staple 282 throughcaptured tissue. Multiple tissue mounds are aspirated into dual suctionports 284 separated by a split partition wall 286. Presence of partitionwall causes the aspirated tissue to form into two separate mounds aroundthe partition wall 286. As shown in FIG. 24, a gap 288 in the partitionwall is provided to allow the stapled tissue portions to be removed fromthe vacuum chamber 290 without having the staple become caught on thepartition wall 286.

[0077] In operation, after the tissue mounds are aspirated into thevacuum chamber 290, a staple 282 is advanced distally by pusher rod 292,which may be guided through a working channel of the endoscope. Thepusher rod advances distally to cause a staple to penetrate both moundsof tissue 138 and engage anvils 294 that cause the ends of the staple tobuckle and collapse to secure the staple in the tissue as a conventionalstaple performs.

[0078] To permit the device to make multiple plications with oneintubation, the staple magazine 296 may be provided to advancesequential staples in line with the pusher rod 292 as each precedingstaple is ejected. The magazine 296 may comprise a housing 298 withspring 299 keeping a constant force against the supply of staples sothat they will eject from the housing automatically as each staple isejected and the pusher rod 292 returns proximally past the magazineposition so that a staple may be ejected into the pusher shaft pathway297.

[0079]FIG. 25 shows another embodiment of the integratedendoscope/accessory concept providing an apposition device 300 havingmultiple access ports 302 through which tissue can be grasped andmanipulated. Tissue may be grasped through the ports 302 by means suchas forceps 304 as shown in FIG. 25. The forceps 304 may be advancedthrough working channels 308 and bend upward at articulation points 310to extend through the access ports 302 to grasp tissue portions 138. Asthe forceps are withdrawn back through the access ports 302, the tissuemounds form as they engage the sides of the ports and are pulled in tothe device.

[0080] Once grasped, the tissue mounds 138 may be injected with a bioabsorbable bulking agent by a needle introduced through another channelof the endoscope. Alternatively, the tissue mounds may be retained byplacement of a ligating band of on each tissue mound. The tissue moundsmay be grasped through the access ports by other means such as a barbedharpoon, a snare loop or rollers.

[0081] As shown in FIG. 26, the grasping mechanisms may be employedthrough an open distal end of an endoscope embodiment 312 providing asingle access port 314. FIG. 26 shows a progression of steps in which agrasping device such as a forceps 304 is first navigated within the openchamber 313 at the distal end of the endoscope 312 and guided to atissue location 315. When the desired tissue location is reached, theforceps 304 is advanced from the open chamber 313 and expanded to graspa tissue portion. Once the tissue portion is grasped, the forceps areclosed to pull it into the open chamber 313 of the endoscope 312 todefine a tissue mound 138 that can then be manipulated with a tissuesecuring device.

[0082] It should be understood however, that the foregoing descriptionof the invention is intended merely to be illustrative thereof and thatother modifications, embodiments and equivalents may be apparent tothose who are skilled in the art without departing from its spirit.Having thus described the invention what we desire to claim and secureby letters patent is:

1. An integrated endoscope and medical treatment accessory comprising:an endoscope shaft having a treatment accessory integrated at its distalend; at least one accessory control element extending through the lengthof the endoscope; and an accessory control mechanism mounted at theproximal end of the endoscope.
 2. An integrated endoscope as defined inclaim 1 wherein the treatment accessory further comprises a tissueapposition device comprising at least one section port and at least oneneedle longitudinally slidable through the accessor to penetrate tissueaspirated into the suction port.
 3. An integrated endoscope as definedin claim 1 wherein the treatment accessory comprises a tissue appositiondevice formed as a cylindrical cartridge that mounts over a reduceddiameter portion of the endoscope.
 4. An integrated endoscope as definedin claim 3 wherein the cylindrical cartridge further comprises a sidesuction port and at least one tissue capturing means that is advancedthrough captured tissue along a circumferential path that rotates abouta longitudinal access of the endoscope.
 5. An integrated endoscope asdefined in claim 4 wherein the suction port further comprises a petitionwall that forces aspirated tissue to form into two separate tissuemounds.
 6. An integrated endoscope as defined in claim 1 wherein thetreatment accessory comprises a tissue suturing device having at leastone suction port and vacuum chamber and a semi-circular needleconfigured to be advanced in a circular path that traverses the vacuumchamber and tissue aspirated therein.
 7. An integrated endoscope asdefined in claim 1 wherein the treatment accessory further comprises atissue apposition device having at least one suction port and vacuumchamber having a bottom surface and an optical viewing port and air andwater port are present on the bottom surface.
 8. An integrated endoscopeas defined in claim 7 wherein the treatment accessory further comprisesan optical viewing port and air and water port located at a distal tipof the endoscope accessory.
 9. An integrated endoscope as defined inclaim 1 wherein the treatment accessory further comprises a tissueapposition device having an angulated distal face that is oriented at anacute angle from the longitudinal access of the endoscope; a suctionport opened on the distal face to a vacuum chamber having a back wallsurface; an optical viewing port and vacuum port arranged on the backwall surface of the vacuum chamber and a needle configured to beadvanced so that it traverses the vacuum chamber at an orientation thatis parallel to the distal face.
 10. An integrated endoscope as definedin claim 1 where in the treatment accessory further comprises a tissueapposition device having a suction port with a partial petition wall todivide tissue aspirated into the port into two portions; at least onestaple oriented to be advanced through captured tissue portions andclosed upon an anvil located at a distal end of the accessory, and astaple driver for advancing a staple longitudinally through theaccessory and captured tissue portions.
 11. An integrated endoscope asdefined in claim 1 wherein the treatment accessory further comprises; atleast one access port adjacent the distal end of the endoscope and atissue grasping device arranged to be advanced through the access portand operated to grasp tissue and pull it through the access port intothe accessory.
 12. A method of performing an endoscopic medicalprocedure comprising: providing an endoscope having an integratedmedical treatment accessory at its distal end, inserting the distal endof the endoscope into a patient and navigating it to a treatment sitecarrying out a medical procedure involving manipulation of internaltissues, without introducing a secondary medical device through theendoscope or external to the endoscope, and withdrawing the endoscopefrom the patient.